Oligonucleotides are short, single-stranded chains of nucleic acids composed of up to 20 nucleotides.
Our GMP Aseptic Filling capabilities for oligonucleotides are designed to support your pharmaceutical drug development journey from clinical trials to commercial production. Our pharmaceutical cGMP Manufacturing Facility is equipped for aseptic liquid filling and aseptic powder filling into vials. Dalton utilizes peristaltic filling equipment with low hold-up volumes, minimizing losses during the filling process and ensuring the preservation of your valuable drug product.
The aseptic fill suite at Raleigh Molecular maintains a localized Grade A (ISO Class 5) environment specifically for filling operations. Our Microbiology Laboratory conducts regular monitoring of all areas within our cGMP aseptic processing facility, focusing on viable airborne contamination, viable contamination on surfaces, and non-viable airborne contamination. These rigorous monitoring practices ensure the maintenance of high-quality standards and compliance with regulatory requirements.
We prioritize flexibility and are dedicated to the success of your oligonucleotide program and pharmaceutical drug development efforts. Unlike some sterile fill companies that may require a minimum number of vials, Raleigh Molecular welcomes small-scale aseptic fills. This approach allows us to swiftly move your project into clinical phases and assist in achieving crucial milestones without unnecessary barriers.
Raleigh Molecular offers comprehensive GMP Aseptic Filling services, including filling and capping of liquid in-vial injectable drugs, as well as aseptic powder filling and capping tailored for preclinical and early-stage clinical trials. Our integrated approach ensures high-quality and compliant filling solutions for your pharmaceutical development needs.
For sterile liquid injectables, Raleigh Molecular conducts aseptic filling using a state-of-the-art fill/finish crimp-cap line. This line is capable of aseptically filling vials ranging from 1 to 125 ml in volume. We have established and validated processes for sterile filling of 2, 3, 5, and 20 ml vials, accommodating production runs of up to 15,000 units per run. These validated processes ensure the reliability and quality of the filled injectable products.
Supporting our process equipment at Raleigh Molecular are validated services such as a WFI (Water for Injection) system, pure steam generator, autoclave, and depyrogenation oven. Our validation capabilities encompass a wide range of activities including aseptic fill simulation studies, terminal sterilization loads, autoclave loads, depyrogenation oven loads, container closure integrity testing, and process validation. Raleigh Molecular also possesses the capability to develop or transfer technology related to aseptic processing as needed.
Additionally, Raleigh Molecular’s analytical service laboratory offers comprehensive services including method development, validation, and ICH stability programs tailored to our clients’ needs. Our QC/QA and Microbiology functions further support our sterile manufacturing services, ensuring adherence to stringent quality standards throughout the manufacturing process.
Raleigh Molecular is actively engaged in manufacturing and filling sterile clinical trial products under cGMP standards. Our experienced aseptic fill finish team is committed to being an extension of your company, offering reliable and responsive services to expedite your progress through the clinical trial process. We understand the importance of efficiency and precision in this critical stage of drug development and are dedicated to supporting your timelines and goals.
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